News

Roche expands the COVID-19 PCR test portfolio to the new cobas 5800 System in countries accepting the CE Mark

22.02.2022

  • Roche continues to increase access to accurate, timely and reliable diagnostics in the fight against COVID-19 by expanding the COVID-19 PCR portfolio on the cobas 5800 System 
  • These tests are for the qualitative detection of SARS-CoV-2 and the qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus
  • As communities across the globe still need effective solutions for COVID-19, Roche will continue to invest in diagnostics to ensure there are testing options available to healthcare communities and patients worldwide

 

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the expansion of the COVID-19 PCR portfolio to the cobas® 5800 System, a recently launched molecular laboratory instrument, in countries accepting the CE mark. These include cobas SARS-CoV-2 Qualitative and cobas SARS-CoV-2 & Influenza A/B tests. These launches expand the Roche Diagnostics molecular portfolio offering by providing standardized performance and efficiencies across low, medium and high volume molecular laboratory testing needs. In addition, the new compact cobas 5800 System broadens access for healthcare systems with limited resources or space. This means better access to testing in countries or environments where there isn’t enough space or resources to accommodate larger instruments. 

Roche offers a comprehensive portfolio of infectious disease tests along the continuum of care, enabling laboratories to provide the right information from screening to diagnosis, for patient management and treatment monitoring.


said Cindy Perettie, Head of the Molecular Lab Customer Area, Roche Diagnostics

Patients are at the heart of our diagnostics solutions and we are pleased that we can increase access to accurate, timely and  reliable diagnostics with our COVID-19 portfolio on the cobas 5800 System to meet evolving testing demands.

 

The COVID-19 portfolio adds to the infectious diseases menu - HIV-1, HBV, HCV, HIV-1/HIV-2 Qualitative - and cobas omni Utility Channel for use on the cobas 5800 System in countries accepting the CE Mark launched in December 2021. The cobas 5800 System will offer the same menu as the cobas 6800 and 8800 Systems. Roche is pursuing CE approval for continued menu expansion on the cobas 5800 System, through early-to-mid 2022. Roche anticipates tests to be available beyond CE markets in additional countries in 2022.

About the tests

SARS-CoV-2: cobas SARS-CoV-2 Qualitative is intended for the qualitative detection of SARS-CoV-2. The test supports nasal, nasopharyngeal and oropharyngeal swabs and saliva specimens.

SARS-CoV-2, influenza A, influenza B: cobas SARS-CoV-2 & Influenza A/B is intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus RNA in nasal and nasopharyngeal swabs.

About the cobas 5800 System

The cobas 5800 System, a compact new addition to the Roche Diagnostics Molecular Work Area, is built upon the innovation of the cobas 6800 and 8800 Systems, making molecular testing accessible to more patients around the world.

The cobas 5800 System is a real-time PCR molecular testing solution that provides excellent performance and value-added utility from a compact footprint. The cobas 5800 System delivers automation, consolidation, integration and standardization – making it a scalable, cost-efficient solution for smaller labs seeking big laboratory performance, or for bigger laboratories seeking small lab agility.

The system is built to offer a fully automated workflow that encompasses sample supply, transfer and preparation, amplification and detection, result calculation and delivery to the laboratory information system (LIS). The single module enables a walkaway time of at least 4 hours*, resulting in less hands-on time, which can lead to improved productivity, reduced possibility for errors and more predictable turnaround times.

The cobas 5800 System offers an expanded on-board capacity allowing laboratories to test multiple assays simultaneously and deliver up to 144 results in an eight-hour shift. This streamlined molecular testing system will allow most labs to consolidate greater than 90 percent** of their routine molecular tests onto a single platform.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalized healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognized as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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* Walkaway time is dependent on the number of tests performed and number of runs initiated (under continuous testing conditions >96 tests per shift, walkaway time may be between 4 - 8 hours).

** May vary based on assay availability in your country.

Innovation made accessible

The cobas® 5800 System makes automation, consolidation, integration and standardization more accessible than ever before.